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Global Organization, Local Presence
August 20th 2025Discover Fedegari’s Local Expertise with Global Reach. Fedegari combines global manufacturing excellence with local service agility to deliver high-quality, responsive support across North and South America. Learn how our strategic presence and expert teams help pharmaceutical companies optimize sterile process solutions.
Rising to Meet New Industry Standards
August 20th 2025Fedegari Training Academy: Building Competence for Evolving Pharma Needs. As pharmaceutical technologies advance, so must the skills behind them. Fedegari’s Training Academy offers hands-on, expert-led programs in a cGMP-compliant environment near Philadelphia—empowering your team to meet modern regulatory and operational challenges with confidence.
From Equipment Manufacturer to Solution Provider
August 20th 2025Fedegari: Customized Process Solutions for Pharma Manufacturing. Fedegari has evolved into a true solution provider—offering integrated, tested, and regulatory-ready systems tailored to your specific process needs. From process development to tech transfer, discover how our expertise minimizes risk and accelerates implementation.
Decentralized Trials: The Value of Direct-to-Patient & Pharmacy-Led Solutions
August 13th 2025Discover how pharmacy-led models in direct-to-patient clinical supply are pivotal in modernizing clinical trials, offering scalable, patient-centric solutions that align with regulatory guidance and industry trends. Strategic collaboration with pharmacy providers is the key to unlocking the full potential and benefits of decentralized clinical trials (DCTs).
Demand-Led Clinical Supply Model for Program-level Product Pooling in Global Decentralized Study
August 13th 2025Global decentralized trials require fast, efficient, and sustainable clinical supply solutions. This case study shows how a biopharma company worked with Catalent’s FastChain® demand-led model to improve supply by reducing waste and shipments by 40%, speeding patient dosing to under three weeks, and enabling flexible, decentralized packaging and distribution, whilst supporting an eco-friendly trial management worldwide.
European Clinical Supply Planning – Balancing Cost, Flexibility & Time
August 13th 2025Choosing the best location for packaging and distributing clinical supplies depends on various study factors and business needs. There’s no one-size-fits-all answer, but by evaluating key considerations, sponsors can determine whether the EU or non-EU countries like the UK best fit their clinical supply strategy.
Optimizing Clinical Trials in China with Strategic Solutions for Supply Chain Challenges
August 13th 2025China is a key player in global clinical trials, yet its intricate regulatory environment and logistical challenges demand meticulous supply chain management. Catalent provides tailored services such as Free Trade Zones, temperature-controlled shipping, and local comparator sourcing to support sponsors in executing trials effectively and in compliance with regulations.
Vial Adapter Considerations for Cell and Gene Therapy Applications
August 5th 2025The landscape of cell and gene therapy is rapidly evolving, with increasing approvals for diverse indications. Preserving the integrity and efficacy of cell and gene therapy products is critical. Vial adapters facilitate the transfer of drug product from a vial by securing an efficient connection between the vial and the administration device. Learn more about how sterility and accurate dosing are maintained while preserving stability.
Executive Summary: End-To-End Regulatory CDMO Solutions: Development, Manufacturing, and Approval
July 25th 2025The road to market access is long and complex. Choosing a CDMO with experienced staff can prove vital to success. In this executive summary, Praveenkumar Devakadaksham and Dr. Roché Marcel Walliser explain all the ways they help make the journey from pharmaceutical development to commercial distribution as smooth as possible. Learn more about:
The Role of On-Demand Manufacturing and Derisking in Accelerating Early Clinical Trial Success
June 4th 2025Small pharmaceutical companies are constantly seeking innovative solutions to streamline early clinical trials. Adaptive clinical trials offer important benefits to sponsors and patients, both from a commercial and ethical standpoint. These trials offer flexibility and efficiency, especially in the early stages, where trial protocols can be adjusted based on interim data, such as introducing new doses or modifying participant sample size. However, adjusting manufacturing demand during an adaptive trial can be complicated, and strict regulatory requirements present significant challenges. On-demand manufacturing provides a robust solution, allowing for real-time supply and demand adjustments and improved trial flexibility. This paper explores how on-demand manufacturing meets the operational needs of adaptive trials and aligns with regulatory expectations.
Fast and Efficient Sialic Acid Clone Selection Using Lectin-Based High-Throughput Screening
June 2nd 2025Glycosylation is a common and critical post-translational modification that affects protein function and therapeutic efficacy, making its monitoring and accurate quantification essential for drug development.
Core2Scan® System: Precise Asset Management for Regulated Industries
May 29th 2025Created specifically for the pharma biotech industry by Veltek Associates, Core2Scan is the tracking, asset management, and process improvement solution that boosts bottom lines and so much more. Powered by RFID, Core2Scan keeps tabs on any onsite physical asset your organization wants to track. Better yet, its invaluable data can drive smarter processes and savings throughout your entire G-M-P facility.